The Next Revolution in Endoscopic Ultrasound Guided Biopsy ... Limaca, Brief Overview Product: KORA,

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Transcript of The Next Revolution in Endoscopic Ultrasound Guided Biopsy ... Limaca, Brief Overview Product: KORA,

  • The Next Revolution in Endoscopic Ultrasound Guided Biopsy Products

    Company Presentation

    February 2019

    Assaf Klein, CEO

    Carl Rickenbaugh, Chairman

  • Legal Disclaimer IMPORTANT NOTICE

    This presentation has been prepared by Limaca Ltd. (the “Company”) solely for informational purposes. The information contained herein has been prepared to assist prospective investors in making their own evaluation of the Company and does not purport to be complete or to contain all of the information a prospective or existing investor may desire. In all cases, interested parties should conduct their own investigation and analysis of the Company and the data set forth in this information. The Company has prepared this presentation based on information available to it, including information derived from public sources that have not been independently verified. The Company makes no representation or warranty as to the accuracy or completeness of this information and shall not have any liability for any representations (expressed or implied) regarding information contained in, or for any errors omissions in, this presentation. This presentation includes certain statements and estimates provided by the Company with respect to the projected future performance of the Company. Such statements, estimates and projections reflect various assumptions by management concerning possible anticipated results, which assumptions may or may not be correct. No representations are made as to the accuracy of such statements, estimates or projections. This presentation may contain statements that are not historical facts, referred to as “forward looking statements.” The Company’s actual future results may differ materially from those suggested by such statements. No assurance can be given that future events will occur or that projections will be achieved. Past performance is not a reliable indication of future performance. This presentation is not, and nothing in it should be construed as, an offer, invitation or recommendation in respect of the Company’s securities, or an offer to sell, or a solicitation of an offer to buy, the Company’s securities in any jurisdiction. Neither this presentation nor anything in it shall form the basis of any contract or commitment. Prospective investors should not construe the contents of this presentation as business, legal, tax, investment or other advice. Each prospective investor should make his, her or its own inquiries and consult his, her or its own advisors as to the appropriateness and desirability of an investment in the Company and as to business, legal, tax and related matters concerning an investment in the Company.

    An investment in the Company shall be allowed only to such number and category of investors in accordance with applicable laws and regulations and pursuant to a predetermined process. Accordingly, detailed information in connection with the investment shall be revealed and delivered only to a limited number of qualifying investors as provided by law.

  • Limaca, Brief Overview  Product: KORA, an electro-mechanically driven Endoscopic Ultrasound (EUS)

    Guided Biopsy Product for improved tumor diagnosis of GI system tumors

     Clinical study: Q1 2019, acute study, 1 week follow up

     Strong team: Led by three highly accomplished executives with medical endoscopic, medical device engineering, and biopsy medtech expertise

     Investors:

    Limaca’s groundbreaking biopsy product will advance precision medicine and enable improved diagnosis and prognosis.

  • KORA- Revolutionizing US Guided Endoscopic Biopsy

    KORA obtains higher quality core tissue for

     superior histopathologic analysis

     improved diagnostic accuracy

     better clinical outcomes

  • Electromechanical Core Tissue Cutter Proven superior sampling

    v. today’s best performing manual product

    Single sample Multi sample 3 stabs

    KORA GI 22G Obtained better core samples

    Multi sample 2 passes X 10 stabs

    SharkCore 22G (Medtronic) Control


  • Diagnosis



    Used for diagnostic and staging for evaluation of benign and malignant diseases of GI tract and of adjacent organs.

    A nonsurgical, minimally invasive procedure which combines:

    • An imaging ultrasound during an endoscopic procedure to look through the wall of internal organs in the chest, abdomen and the GI tract

    • And a thin, hollow needle inserted into a mass for sampling of tissue specimen (Biopsy) followed by cytological / histological examination.

    Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

  • Limaca’s Initial Focus: Pancreatic Tumors

     55,000 Americans will be diagnosed with pancreatic cancer this year1

     ~9% survival rate

     Every pancreatic tumor is different, requiring specific diagnosis3

    Sources: Pancreatic Cancer Network American Cancer Society

    Future markets in Limaca’s pipeline include Liver and Lung cancer

  • Current Biopsy Products are Inadequate…


    Limitations of manually operated Endoscopic Ultrasound (EUS) Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) products

    Multiple stabbing of lesion (often 20-70x)

    Imprecise stabbing Small sample suitable for cytological (cell)

    analysis only

    70-80% tissue acquisition rate

  • …The Result

    • Injury to organ tissue

    • Significantly longer procedure

    • Additional stabs and time to reach the target tissue

    • Frustrated gastroenterologist

    • Of 10 biopsies, 2 to 3 will fail

    • Patients need to come back for repeat procedures

    • Unable to perform advanced analysis *

    • Inability to provide personalized medicine *

    * The limitation to obtain only a small sample suitable for cytological (cell) analysis only, means that advanced analysis of tumor type cannot be performed, so therapy cannot be tailored to the exact tumor type, potentially resulting in suboptimal therapy. Advanced analysis involves molecular profiling: analyzing patient’s DNA, RNA, and protein in cancer cells

  • KORA GI: Win-Win for All

    Physician  Better quality sample  Larger tissue sample  One needle pass and fewer

    stabs (lesions)  Improved acquisition rate

    Patient  Improved diagnosis  Better prognosis  Reduced risk of infection and

    hospitalization  Enables personalized medicine

    Healthcare facility  Quicker procedure

    (estimated savings ~10-15 minutes)

     Reduced need for repeat biopsy procedures

     Reduced risk of potential complications

    “We must have needles that provide a higher tissue yield with fewer passes, to improve diagnosis and drive patient specific therapy to achieves better outcomes”

    Robert Hawes, MD Medical Director, Florida Hospital Center for Minimally Invasive Therapy

  • IP, Regulatory and Reimbursement

     Robust patent protection

     CE and FDA submission will follow clinical study

    ▫ CE Class IIa

    ▫ FDA Class II, 510(k) pathway

     Reimbursement codes in place

  • Global Endoscopic Ultrasound Biopsy Product Market attractive market, responsive to better technology

    1.1 million procedures  $300 million market

    Major market players today None have electromechanical products, all are manual

    Potential for New Entrants via Acquisition:

    Many Additional Large Global Medical Device and Diagnostic Companies are looking to expand their oncology and surgical product portfolios. So, there is high potential for Limaca to attract additional potential acquirers seeking to enter this space with unique products that have the potential for undisputed product leadership to drive revenue growth

  • KORA Market Potential


     KORA market launch: 2023

     Total EUS biopsy procedures ~811,000 (2023); KORA market potential >$190 million

     Total procedures expected to reach 897,000 (2026); KORA market potential >$215 million


     KORA market launch:2021

     Total EUS biopsy procedures ~357,000 (2021);

    KORA market potential >$120 million

     Total procedures expected to reach 422,000 ( 2026); KORA market potential >$140 million

  • Market Moving Towards Precision Medicine

     For improved, personalized tumor diagnosis and treatment

     Based on molecular profiling; analyzing patient’s DNA, RNA, and protein in cancer cells

     Requires high quality tissue sample

     Matches patient with the best treatment

    Limaca’s KORA GI will advance precision medicine and enable

    improved diagnosis and better prognosis.

  • Experienced Team ASSAF KLEIN, CEO

    17 years’ experience in medical device companies, including managerial and R&D positions; former CEO, MediValve; MBA, Bar-Ilan University; B.Sc., mechanical engineering, Technion Israel Institute of Technology, Israel.


    Director, Invasive Endoscopy Unit, Department of Gastroenterology and Hepatology, Rambam Health Care, Israel; entrepreneur and inventor.


    President, First Keel Consulting; former Management Board Member and Vice P